AU2005325930B2 - Extended release formulation of Levetiracetam - Google Patents

Extended release formulation of Levetiracetam Download PDF

Info

Publication number: AU2005325930B2
Authority: AU; Australia
Prior art keywords: levetiracetam; extended release; weight; core; coated
Prior art date: 2005-01-27
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Ceased

Application number

AU2005325930A

Other languages

English (en)

Other versions

AU2005325930A1 (en

Inventor

Mayank Joshi

Rajesh Kshirsagar

Yogesh Raichandani

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Alembic Ltd

Original Assignee

Alembic Ltd

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2005-01-27

Filing date

2005-08-12

Publication date

2012-01-19

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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35788072&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2005325930(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2005-08-12 Application filed by Alembic Ltd filed Critical Alembic Ltd

2006-08-03 Publication of AU2005325930A1 publication Critical patent/AU2005325930A1/en

2012-01-19 Application granted granted Critical

2012-01-19 Publication of AU2005325930B2 publication Critical patent/AU2005325930B2/en

2025-08-12 Anticipated expiration legal-status Critical

Status Ceased legal-status Critical Current

Links

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238000006703 hydration reaction Methods 0.000 description 1
239000000017 hydrogel Substances 0.000 description 1
239000008172 hydrogenated vegetable oil Substances 0.000 description 1
WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
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KHLVKKOJDHCJMG-QDBORUFSSA-L indigo carmine Chemical compound [Na+].[Na+].N/1C2=CC=C(S([O-])(=O)=O)C=C2C(=O)C\1=C1/NC2=CC=C(S(=O)(=O)[O-])C=C2C1=O KHLVKKOJDHCJMG-QDBORUFSSA-L 0.000 description 1
235000012738 indigotine Nutrition 0.000 description 1
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230000003993 interaction Effects 0.000 description 1
UQSXHKLRYXJYBZ-UHFFFAOYSA-N iron oxide Inorganic materials [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 1
125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
150000002632 lipids Chemical class 0.000 description 1
235000010420 locust bean gum Nutrition 0.000 description 1
239000000711 locust bean gum Substances 0.000 description 1
230000001050 lubricating effect Effects 0.000 description 1
HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 description 1
239000000391 magnesium silicate Substances 0.000 description 1
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238000004519 manufacturing process Methods 0.000 description 1
239000013563 matrix tablet Substances 0.000 description 1
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239000001923 methylcellulose Substances 0.000 description 1
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235000019198 oils Nutrition 0.000 description 1
NDLPOXTZKUMGOV-UHFFFAOYSA-N oxo(oxoferriooxy)iron hydrate Chemical compound O.O=[Fe]O[Fe]=O NDLPOXTZKUMGOV-UHFFFAOYSA-N 0.000 description 1
230000036961 partial effect Effects 0.000 description 1
229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 description 1
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238000004513 sizing Methods 0.000 description 1
239000011734 sodium Substances 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
235000015424 sodium Nutrition 0.000 description 1
LLELVHKMCSBMCX-UHFFFAOYSA-M sodium 1-[(4-chloro-5-methyl-2-sulfophenyl)diazenyl]naphthalen-2-olate Chemical compound [Na+].Cc1cc(N=Nc2c(O)ccc3ccccc23)c(cc1Cl)S([O-])(=O)=O LLELVHKMCSBMCX-UHFFFAOYSA-M 0.000 description 1
235000010413 sodium alginate Nutrition 0.000 description 1
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UWHCKJMYHZGTIT-UHFFFAOYSA-N tetraethylene glycol Chemical compound OCCOCCOCCOCCO UWHCKJMYHZGTIT-UHFFFAOYSA-N 0.000 description 1
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WEAPVABOECTMGR-UHFFFAOYSA-N triethyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCOC(=O)CC(C(=O)OCC)(OC(C)=O)CC(=O)OCC WEAPVABOECTMGR-UHFFFAOYSA-N 0.000 description 1
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ZIBGPFATKBEMQZ-UHFFFAOYSA-N triethylene glycol Chemical compound OCCOCCOCCO ZIBGPFATKBEMQZ-UHFFFAOYSA-N 0.000 description 1
235000013976 turmeric Nutrition 0.000 description 1
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229920001285 xanthan gum Polymers 0.000 description 1
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XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
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Classifications

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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

Health & Medical Sciences (AREA)
Public Health (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
General Chemical & Material Sciences (AREA)
Neurology (AREA)
Neurosurgery (AREA)
Chemical Kinetics & Catalysis (AREA)
Biomedical Technology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Pain & Pain Management (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

AU2005325930A 2005-01-27 2005-08-12 Extended release formulation of Levetiracetam Ceased AU2005325930B2 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
IN81MU2005		2005-01-27
IN81/MUM/2005		2005-01-27
PCT/IN2005/000275 WO2006080029A1 (fr)	2005-01-27	2005-08-12	Formulation de lévétiracétam à libération prolongée

Publications (2)

Publication Number	Publication Date
AU2005325930A1 AU2005325930A1 (en)	2006-08-03
AU2005325930B2 true AU2005325930B2 (en)	2012-01-19

Family

ID=35788072

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
AU2005325930A Ceased AU2005325930B2 (en)	2005-01-27	2005-08-12	Extended release formulation of Levetiracetam

Country Status (18)

Country	Link
US (4)	US7858122B2 (fr)
EP (1)	EP1843761B1 (fr)
JP (1)	JP5739080B2 (fr)
KR (1)	KR20070095456A (fr)
CN (1)	CN101111245A (fr)
AU (1)	AU2005325930B2 (fr)
BR (1)	BRPI0518506A2 (fr)
CA (1)	CA2595988A1 (fr)
DE (1)	DE05815688T1 (fr)
EA (1)	EA014249B1 (fr)
ES (1)	ES2294979T1 (fr)
IL (1)	IL184822A0 (fr)
MX (1)	MX2007009088A (fr)
NO (1)	NO20074316L (fr)
NZ (1)	NZ556630A (fr)
UA (1)	UA89216C2 (fr)
WO (1)	WO2006080029A1 (fr)
ZA (1)	ZA200707250B (fr)

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- 2005-08-31 US US11/215,947 patent/US7858122B2/en active Active
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- 2006-10-20 US US11/583,888 patent/US7863316B2/en active Active
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2010
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Publication number	Publication date
US20070092569A1 (en)	2007-04-26
ZA200707250B (en)	2009-06-24
MX2007009088A (es)	2007-09-13
US20110064807A1 (en)	2011-03-17
WO2006080029A1 (fr)	2006-08-03
BRPI0518506A2 (pt)	2008-12-02
CN101111245A (zh)	2008-01-23
JP2008528571A (ja)	2008-07-31
CA2595988A1 (fr)	2006-08-03
US20110064808A1 (en)	2011-03-17
UA89216C2 (ru)	2010-01-11
KR20070095456A (ko)	2007-09-28
ES2294979T1 (es)	2008-04-16
EP1843761A1 (fr)	2007-10-17
EP1843761B1 (fr)	2018-01-31
NZ556630A (en)	2010-12-24
IL184822A0 (en)	2007-12-03
NO20074316L (no)	2007-08-23
US7863316B2 (en)	2011-01-04
AU2005325930A1 (en)	2006-08-03
US7858122B2 (en)	2010-12-28
JP5739080B2 (ja)	2015-06-24
US20060165796A1 (en)	2006-07-27
EA014249B1 (ru)	2010-10-29
DE05815688T1 (de)	2008-06-26
EA200701575A1 (ru)	2008-02-28

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